NEW YORK (GenomeWeb) – Researchers from the University of Pittsburgh, working with local health service organizations and Coriell Life Sciences, are embarking on a study to demonstrate that using genetic information to inform medication choices for patients with mental illnesses can save money and results in better outcomes.
Announced this week, the project — funded by a grant of $350,000 from the Polk Foundation — will recruit about 400 patients from two clinical sites in western Pennsylvania through NHS Health Services, which provides services to adult mentally ill patients in the area.
The group intends to draw on participants who are currently prescribed or will be prescribed at least one psychotropic medication during the study period. Robin Grubs, director of Pitt's genetic counseling program, will oversee recruitment and consenting of these subjects, the team said.
Dietrich Stephan, professor and chair of the Department of Human Genetics at the Pitt Graduate School of Public Health, told GenomeWeb in an email that a company called CareKinesis — a medication management and distribution pharmacy — will analyze participants' genetic makeup using Coriell's genotyping platform to identify variants that contribute to variations in response to or adverse outcomes from psychiatric medications.
Separately, Coriell and CareKinesis, along with IBM, are also collaborating on a project to analyze and store genetic data from elderly patients in an effort to improve and better manage their medication regimens.
In the new study of mental health patients, clinicians will treat subjects from one of the two NHS sites in light of their genetic test results, with modifications made to their dosing or prescriptions where indicated. Those at the other site will be managed using standard clinical decision-making without taking genetics into account.
According to Stephan, chair of the clinical advisory panel for the 28-month initiative, the study is not aimed at identifying new correlations between genetic markers and drug response, but rather in defining the clinical utility and cost savings of established genetic markers linked to established drugs.
In using Coriell's platform, the group hopes it can inform decisions regarding a wide number of drugs. "Our population is on an average of 10 medications for a variety of indications. Thus we need to be as comprehensive as possible in our genotyping approach," he wrote.
Coriell's PGx genotyping service, called GeneDose, uses Fluidigm technology to type variants in 20 genes known to be hypervariable, affect drug metabolism, and increase risk for adverse reactions, Coriell President and CEO Scott Megill told GenomeWeb.
"We provide specific clinical advice for more than 60 drugs across multiple drug classes with comprehensive coverage for psychiatric, cardiac, and pain management treatments, in particular," he said in an email.
Once patients have been genotyped, the U Pitt team plans to follow the cohort for 24 months, measuring medication-related problems, such as adverse drug responses, and comparing their incidence in the two groups.
"We will measure the number of emergency room visits, hospital admissions, and mortality between the groups. We will also measure medication adherence, time to therapeutic response, and treatment successes of pyschiatric medications between study arms," Stephan explained.
Importantly, the researchers also intend to calculate whether medical costs differ for the two cohorts in an attempt to demonstrate that they can be reduced by managing mentally ill patients' medications using genetic information.
According to Stephan, "roughly 1 million individuals in the US alone are admitted to the hospital every year for medication-related adverse events. Approximately 100,000 individuals die each year from such adverse drug responses. A significant portion of these individuals are in the high-risk groups who take a multitude of medications: the elderly and the mentally ill."
If the team is able to collect meaningful health economic data, they hope it can serve as a source of evidence to support insurance company reimbursement of mental health genetic test services like Coriell's.
At least one company offering services for personalizing mental health medications using genetic information has announced some important successes in adoption and reimbursement recently.
Testing company Assurex Health said last year that the US Department of Veterans Affairs had approved a contract that will allow it to provide its GeneSight Psychotropic test to VA doctors nationwide through June 2019.
In October, Medicare contractor Palmetto GBA also finalized its local coverage determination for GeneSight, agreeing to reimburse for the test for certain beneficiaries suffering from depression.